| Did
you know? You’ve
probably heard of ADHD. You might even suffer
from it. People who suffer from ADHD have a hard
time paying attention. They get distracted. They
procrastinate. They have a hard time getting organized
and finishing work. They misplace their stuff.
They may feel restless.
But did you know that teens with ADHD can also
have serious problems with drugs? If you are a
teen with ADHD who also uses drugs, you are more
likely than other teens who use drugs to drop
out of school, get into trouble, and have a harder
time kicking your drug habit.
Why is this? One reason may be that many teens
in drug programs don’t get medication for
their ADHD while they are in treatment.
The purpose of this study is to find out if Osmotic-Release
Methylphenidate (OROS-MPH), a medication approved
for the treatment of ADHD, compared to placebo
(sugar pill), can help teenagers with drug or
alcohol problems. |
 |
Who can be in the Study ?
You can be in this study if you:
- Are 13-18 years old;
- Have ADHD and are willing to take medication
or placebo (sugar pill) for it;
- Have a drug or alcohol problem; and
- Are willing to participate in the Cognitive
Behavioral Therapy (CBT) used in this study
to help you stop using alcohol or drugs.
What if I want to be in the Study ?
- You (and your parent/guardian if you are
under 18) will contact the research clinic
for a confidential telephone screening to
see if you might be able to participate.
- If you qualify based on this screening, you
(and parent/guardian if applicable) will come
in for an appointment at the clinic. At this
visit, the study will be explained to you in
detail and you will be asked in private about
your drug/ alcohol use and your medical history,
including ADHD
- If you still qualify, you will have a
physical exam and blood test to make
sure you are healthy (and a pregnancy
test if female), a urine test for drugs,
and an ECG to check your heart.
You will answer more questions (in
private) about your drug use and ADHD.
- If you meet the criteria, you will be
assigned at random (for example, by
the flip of a coin) to receive OROS-MPH
or placebo. You will be asked to take
the OROS-MPH or placebo every day
for 16 weeks.
-
You will come to the clinic every week for about 2 hours to:
- Participate in 1-hour CBT sessions;
- Answer questions about your drug use and ADHD;
- Give a urine sample to test for drugs of abuse; and
- Meet with a clinician to be sure you are not having any bad reactions to the study medications.
-
At the end of 16-weeks, you will again have a small amount of blood taken.
-
You will come back for a follow-up visit 1 month after your last study visit. In total, you will be in the study for about 5 months.
Questions
Does the medication have any side effects?
The medication in this study may cause side
effects and may react with other medications or
drugs you might be taking. You will be given a
form that lists the possible side effects for
the medications you will take.
While you are in the study, you will be watched
for possible side effects. Still, some side effects
may be harmful and some may be unknown. Ask the
clinician before taking any other
medication or drug.
Is the information I provide private?
There is a small risk that others who are
not involved in the study will see the information
you give us. However, the investigators and their
staffs are well trained in keeping your information
confidential. You will also be given an ID number
that will be used on all forms instead of your
name. In addition, all
information collected from the participants is
kept in locked areas in the clinic.
What if I decide to drop out?
This study is entirely voluntary. You can
withdraw at any time with no penalty to you.
What are the benefits of Cognitive Behavioral
Therapy?
Changing your substance use requires knowing
your patterns of use inside and out. We will explore
these patterns as well as look at particular skills
to help you change your use, such as how to cope
with cravings. All information shared during treatment
is confidential.
As part of your involvement in this study, you
will be offered free treatment for your substance
use. This treatment is called Cognitive-Behavioral
Therapy (CBT). The therapy is a 1-hour session
each week and includes three family sessions which
we will schedule during your time in the study.
CBT has been shown to help in the following areas:
- Reduce substance abuse and relapses;
- Improve family relationships;
- Enhance performance at school;
- Advance communication skills;
- Develop anger management skills; and
- Develop job-seeking skills.
Will I receive anything for participating?
Yes, you will be paid for your time and travel
while participating in this study.
For More Information
For more information on the National Institute
on Drug Abuse Clinical Trials Network, visit the
NIDA web site at www.drugabuse.gov.
For information on other government sponsored
clinical trials, the National
Institutes on Health (NIH) has created a web site
to help patients, family members, and the general
public obtain information about government sponsored
clinical trials. You may log on to www.clinicaltrials.gov
to learn about ongoing or new trials of all types
of health related conditions. The descriptions
for individual trials include eligibility criteria,
purpose of the trial, location, and how to
apply if interested. The web site is maintained
and updated regularly by the National Library
of Medicine.
National Library
of Medicine.
National Institute on Drug Abuse
Center for Clinical Trials Network
6001 Executive Boulevard, MSC 9557
Bethesda, Maryland 20892-9557
Telephone: (301) 443-6697
Fax: (301) 443-2317
|
